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YOUR PARTNER IN VENOUS ABLATIONTreat varicose veins with the full spectrum of VenaCure products.
P3
Procedure Partner
Procedure Kit
Procedure Pack
USA > 14 Plaza Drive, Latham, NY 12110 > tel: 800-772-6446 or 518-798-1215 > fax: 518-798-1360International > Haaksbergweg 75 (Margriettoren), 1101 BR, Amsterdam Z-O > The Netherlandstel: +31 (0)20 753 2949 > fax: +31 (0)20 753 2939
www.angiodynamics.com
*AngioDynamics, the AngioDynamics logo, VenaCure, VenaCure EVLT, the VenaCure EVLT logo, NeverTouch, NeverTouch Direct, the VenaCure Direct logo, the VenaCure Gold logo, PVAK, the VenaCure PVAK logo, Tre-Sheath, Spotlight OPS, and the VenaCure OPS logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary © 2018 AngioDynamics, Inc. ANGB 867 US Rev 01 12/18
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
INDICATION FOR USE: The 400 Micron Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The 400 Micron Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of incompetent (i.e. refluxing) perforator veins (IPVs).
CONTRAINDICATIONS: Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; aneurysmal section in the vein segment to be treated; peripheral artery disease as determined by Ankle Brachial Pressure Index with a value of <0.9; an inability to ambulate; deep vein thrombosis; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised
by the individual physician at the time of treatment.
WARNINGS AND PRECAUTIONS: Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using the VenaCure EVLT Procedure Kits with the 400 Micron Fiber. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications. Laser protective eyewear must be worn by everyone in the treatment room, including the patient.
CAUTION: Intended for use only by fully trained physicians. The VenaCure EVLT Procedure Kit is intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates are still valid. Treatment of a vein located close to the skin surface may result in a skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy.
POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.
400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT: IMPORTANT RISK INFORMATION
INDICATION FOR USE: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.
CONTRAINDICATIONS: Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated.
WARNINGS AND PRECAUTIONS: Treatment of a vein located close to the skin surface may result in skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy. All persons in the treatment room MUST wear protective glasses with the proper rating for the wavelength being used.
CAUTION: This device is ethylene oxide sterilized and intended for single patient use only. Do not reuse or resterilize the fibers. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. Carefully read all directions and observe all Warnings and Precautions prior to performing the procedure.
POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory
nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.
CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician.
NEVERTOUCH DIRECT: IMPORTANT RISK INFORMATION
INDICATION FOR USE: AngioDynamics Laser and VenaCure EVLT Procedure Kits with Spotlight OPS Sheath are indicated for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the great saphenous vein, and with veins in the lower limbs with superficial reflux. The D15 Plus, D30 Plus, Delta-15 and Delta-30 lasers and VenaCure EVLT Kits are indicated for treatment of incompetent refluxing veins in the superficial venous system.
CONTRAINDICATIONS: Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; aneurysmal section in the vein segment to be treated; peripheral artery disease as determined by Ankle Brachial Pressure Index with a value of <0.9; an inability to ambulate; deep vein thrombosis; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.
WARNINGS AND PRECAUTIONS: Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using the VenaCure EVLT Procedure Kits with Spotlight OPS Sheath. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications. Laser protective eyewear must be worn by everyone in the treatment room, including the patient.
CAUTION: Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. The VenaCure EVLT Procedure Kit is intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates are still valid. Treatment of a vein located close to the skin surface may result in a skin burn. Parasthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.
SPOTLIGHT OPS IMPORTANT RISK INFORMATION
AngioDynamics’ VenaCure EVLT endovenous laser vein treatment offers patients a minimally-invasive choice for treating the source of their varicose veins. Studies have shown that laser treatment can provide with quicker recovery and a return to normal daily routines, as compared to surgery1. The VenaCure EVLT System includes a 1470 nm laser and 600 micron or 400 micron laser fiber procedure kits including accessories, marketing materials, support and more. For more information on these products, please visit www.VenaCure-EVLT.com.
Description UPN
Premier Procedure Pack B098114AMS010
Basic Procedure Pack B098114AMS030
Standard Procedure Pack B098114AMS020
Phlebectomy Procedure Pack B098114AMS040
PROCEDURE PACKS
ORDERING INFORMATION
Description UPN Kit Length
Procedure Kit with Spotlight OPS Sheath H787EVLT25OPS5 25 cm
Procedure Kit with Spotlight OPS Sheath H787EVLT55OPS5 55 cm
Procedure Kit with Spotlight OPS Sheath H787EVLT80OPS5 80 cm
SPOTLIGHT OPS
Description UPN Kit Length Long-Access Guidewire Needle
NeverTouch Kit H787114020010 45 cm .035” 21 gauge
NeverTouch Kit H787114020020 65 cm .035” 21 gauge
NeverTouch-FRS Kit H787114030010 45 cm .035” 21 gauge
NeverTouch-FRS Kit H787114030020 65 cm .035” 21 gauge
NeverTouch-FRS Kit H787114030040 90 cm .035” 21 gauge
NeverTouch-FRS Kit H787114030050 45 cm .035” 19 gauge
NeverTouch-FRS Kit H787114030060 65 cm .035” 19 gauge
NeverTouch-FRS Kit H787114030070 90 cm .035” 19 gauge
NeverTouch-FRS Kit H787114030030 25 cm .018” 21 gauge
NeverTouch-FRS Kit H787114030120 45 cm .018” 21 gauge
NeverTouch-FRS Kit H787114030130 65 cm .018” 21 gauge
NEVERTOUCH DIRECT
400 MICRON PERFORATOR & ACCESSORY VEIN ABLATION KIT (PVAK)
Description UPN
400 micron Fiber Kit (PVAK) H787EVLTPVAKUS5
1. Brittenden, J., et al. (2015, April). Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenus laser ablation and surgery for varicose veins: Results from the Comparison of Laser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technology Assessment, 19(27).
PREMIER PROCEDURE PACK
PREMIER PROCEDURE PACK CONTENTS:
• One (1) scalpel #11
• One (1) 32 oz. bowl
• Two (2) towel clamps
• One (1) backtable cover
• Thirty (30) sponges
• One (1) Steristrip
• One (1) U drape
• Ten (10) blank labels
• One (1) probe cover
• One (1) half drape
• One (1) scissors
• One (1) needle 27
• One (1) 10cc syringe
• Six (6) OR towels
• One (1) Chloraprep
• Two (2) extra-large gowns
• One (1) needle 18
• One (1) spinal needle
• One (1) needle counter
• One (1) 20cc syringe
• One (1) skin marker
• Two (2) ultrasound gel
The Premier Endovenous Ablation Procedure Pack from AngioDynamics features everything today’s provider needs to perform venous ablation with the precision of VenaCure.
BASIC PROCEDURE PACK
BASIC PROCEDURE PACK CONTENTS:• One (1) scalpel #11
• One (1) 32 oz. bowl
• One (1) backtable cover
• Twenty (20) sponges
• One (1) U drape
• One (1) probe cover
• One (1) 8 oz. denture cup
• One (1) needle 27
• One (1) 10cc syringe
• Five (5) OR towels
• One (1) extra-large gown
• One (1) needle 18
• One (1) spinal needle 22
• Two (2) 20cc syringes
• Two (2) ultrasound gel
The Basic Endovenous Ablation Procedure Pack from AngioDynamics is a slimmed-down kit perfect for venous ablation practices in need of select supplies.
STANDARD PROCEDURE PACK
STANDARD PROCEDURE PACK CONTENTS:
• One (1) scalpel #11
• One (1) 32 oz. bowl
• One (1) towel clamp
• One (1) backtable cover
• Twenty (20) sponges
• One (1) 40 oz. PVP bottle
• One (1) U drape
• Ten (10) blank labels
• One (1) probe cover
• One (1) 8 oz. denture cup
• One (1) scissors
• One (1) needle 27
• One (1) 10cc syringe
• Six (6) OR towels
• One (1) prep sponge
• One (1) extra-large gown
• One (1) needle 18
• One (1) spinal needle
• One (1) needle counter
• One (1) 20cc syringe
• Two (2) ultrasound gel
The Standard Endovenous Ablation Procedure Pack from AngioDynamics features the essentials for venous ablation, with all pieces achieving the high quality standards of VenaCure products from AngioDynamics.
PHLEBECTOMY PROCEDURE PACK
PHLEBECTOMY PROCEDURE PACK CONTENTS:
• One (1) scalpel #11
• One (1) backtable cover
• One (1) half drape
• One (1) 10cc syringe
• One (1) extra-large gown
• One (1) needle 25
• Thirty (30) sponges
• One (1) OR towel
• One (1) Steristrip
• One (1) U drape
The Phlebectomy Procedure Pack from AngioDynamics includes the integral components for for venous phlebectomy, with all pieces meeting the high standards extpected from VenaCure products from AngioDynamics.
NEVERTOUCH DIRECT* FIBER• Provides same benefits as the NeverTouch* fiber, now with an atraumatic tip for sheathless
placement
• Allows physicians to advance to the saphenofemoral junction without the use of a TRE-Sheath* introducer in appropriate patients
• Allows physicians to gain access, advance the fiber and treat a diseased vein without the placement of a second guidewire
• May result in faster procedures and fewer components
NEVERTOUCH GOLD-TIP FIBER• Gold-tip fiber eliminates laser tip contact with the vein wall, minimizing perforations of the vein
wall that can result in pain and bruising (as compared to traditional bare-tip fibers)
• Gold-tip maximizes ultrasonic visibility
400 MICRON PERFORATOR & ACCESSORY VEIN ABLATION KIT (PVAK*)• 400 micron optical fiber aids in SV access and positioning
• 21G venous access needle ensures easy, atraumatic access
• .018” guidewire navigates small, tortuous veins with a floppy tip and a firm anchor to guide sheath and hold it in place
SPOTLIGHT ONE-PIECE SHEATH (OPS) PROCEDURE KIT• Tungsten-loaded sheath tip increases echogenicity, allowing for bright and easy tip placement,
while the smooth, soft, atraumatic tip and low profile make it easy to navigate
• Unique self-dilation technology eliminates the need for a separate dilator, resulting in fewer components, fewer exchanges, and potentially faster procedures
ANGIODYNAMICS FIBERSThe perfect complement to your AngioDynamics procedure packs.
Perforator & Accessory Vein Ablation Kit